Bausch says court grants summary judgment in favor of FDA, Salix, and Teva

Bausch Health Companies (BHC) and its gastroenterology business, Salix Pharmaceuticals, announced the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals, Inc. v. Kennedy, et al., denied Norwich’s motion for a preliminary injunction treated as a motion for summary judgment in its lawsuit against the U.S. Food and Drug Administration. “Norwich had asked the District Court for a judgment declaring the FDA’s decision to issue tentative approval for Norwich’s Abbreviated New Drug Application for XIFAXAN 550 mg and failure to determine Teva (TEVA) Pharmaceuticals USA had forfeited its 180-day exclusivity were arbitrary, capricious, and contrary to law. Norwich sought an injunction directing the FDA to immediately grant Final Approval to Norwich’s ANDA for XIFAXAN 550 mg. Norwich argued that if upheld, FDA’s determination will prohibit Norwich from marketing those products until at least June 29, 2028, assuming Teva launches its rifaximin product in January 2028. Today, the District Court denied Norwich’s motion and granted summary judgment in favor of the FDA, Salix, and Teva, and closed the case. We are pleased with the ruling issued today by the U.S. District Court. We will persist in advocating for the well-being of patients who have greatly benefited from sustained access to XIFAXAN,” said Bausch Health.